MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) 21G, 1 IN FLASHBACK NEEDLE; SAMPLE NEEDLE

Catalog Number 301746

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Hepatitis (1897)

Event Date 03/29/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).This was reported as one incident but two devices were used.Refer to mfr report # 1917413-2016-00010, which captures the second device used in this incident.(b)(6).

Event Description

It was reported that on the morning of (b)(6) 2016 around 8:40 an off site collection was being performed.The phlebotomist involved used the closed system collection ((b)(4)], adapter, and edta 2ml [(b)(4)]) for blood extraction on patient (b)(6) for a blood test but mistakenly inserted a used and filled edta tube from previous collection of patient (b)(6).The phlebotomist realized the mistake when he/she was about to label the tube and discovered the tube was already labelled and barcoded.Both patients (b)(6) were subjected to blood collection and testing for infectious diseases.(b)(6).

Manufacturer Narrative

(b)(6).Device evaluation: result - a sample was not returned for evaluation.A review of the device history record revealed no nonconformance found during the manufacture of the reported lot number 4321180.No abnormalities were observed after reviewing preventive maintenance, calibration and equipment.Conclusion - bd was not able to duplicate or confirm the customer¿s indicated failure mode.This nonconformance occurred out of the manufacturing facility.Based on the complaint verbatim, user error resulted in using a used and filled edta tube from a previous collection on a different patient.

• Brand Name: 21G, 1 IN FLASHBACK NEEDLE
• Type of Device: SAMPLE NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5592652
• MDR Text Key: 43157338
• Report Number: 8041187-2016-00025
• Device Sequence Number: 0
• Product Code: FMI
• Reporter Country Code: RP
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 06/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Phlebotomist
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: 301746
• Device Lot Number: 4321180
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention